Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma
NCT ID: NCT00002767
Last Updated: 2014-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
1996-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.
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Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by location of metastatic sites (visceral and bone vs nonvisceral and lung) and number of metastatic sites (1 vs 2 vs 3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously (SQ) weekly on weeks 1-5 and 8-12. Interferon alfa (IFN-A) SQ is administered three times a week beginning on week 4. Patients with responding or stable disease receive vaccine monthly beginning on week 16. IFN-A continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive IFN-A SQ three times a week beginning on week 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before, during, and after treatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 300 patients will be entered over 2 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Detox-B adjuvant
recombinant interferon alfa
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times normal No evidence of hepatic failure No active hepatitis Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction within 6 months No decompensating congestive heart failure No unstable angina No current symptomatic arrhythmia Other: No known HIV antibody No thyroid abnormality uncontrollable by medication No medical, sociological, or psychological impediment to study compliance No pre-existing psychiatric condition (especially depression) or history of severe psychiatric disorder No autoimmune disease (e.g., systemic lupus erythematosus, multiple sclerosis, ankylosing spondylitis) No concurrent malignancy except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile women No history of egg allergies
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since interferon alfa or melanoma vaccine No prior immunotherapy for metastatic disease No concurrent cytokines or levamisole Chemotherapy: No prior chemotherapy for metastatic disease At least 4 months since adjuvant therapy No concurrent chemotherapy Endocrine therapy: At least 1 week since corticosteroids No concurrent immunosuppressives (e.g., azathioprine or cyclosporine) Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Principal Investigators
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Kenneth B. Von Eschen, PhD
Role: STUDY_CHAIR
GlaxoSmithKline
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Beckman Research Institute, City of Hope
Duarte, California, United States
University of California San Diego Cancer Center - La Jolla
La Jolla, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Kaiser Permanente Medical Center-Sacramento
Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Kaiser Permanente Medical Group - San Francisco
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Adventist Health System/Sunbelt, Inc.
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Creighton University Cancer Center
Omaha, Nebraska, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Hematology Oncology Consultants Inc
Columbus, Ohio, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Countries
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Other Identifiers
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CORIXA-2885-14
Identifier Type: -
Identifier Source: secondary_id
RIR-2885-14
Identifier Type: -
Identifier Source: secondary_id
YALE-HIC-8666
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-0883
Identifier Type: -
Identifier Source: secondary_id
CDR0000064732
Identifier Type: -
Identifier Source: org_study_id
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